COVID-19NCT05435456
Effect of Exercise on Post-Covid Symptoms
A study testing Exercise in people with COVID-19, run by Halic University at 1 site in Turkey (Türkiye).
Trial summary
The study aimed to investigate the effects of strengthening and relaxation exercises on pain, anxiety, and sleep quality. 76 post-covid patients were randomized into experimental and control groups. Experimental group patients performed strengthening and relaxation exercises 3 times a week for 8 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Jan 2021to 8 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- to be between the ages of 18-65
- to be diagnosed with Covid-19 in the last 3 months
- to have a negative PCR test, or to have completed the 14-day isolation period
Who cannot join
- have undergone surgery in the last 6 months
- have severe mental retardation that would prevent communication
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpaşa Education and Research Hospital
Istanbul
About this study
Official title: Effect of Strengthening and Relaxation Exercises on Musculoskeletal Pain, Anxiety, and Sleep Quality on Post-covid Symptoms
The study aimed to investigate the effects of strengthening and relaxation exercises on pain, anxiety, and sleep quality. 76 post-covid patients were randomized into experimental and control groups. Experimental group patients performed strengthening and relaxation exercises 3 times a week for 8 weeks. Control group patients did not perform any program. All participants were assessed with McGill Pain Scale short form (SFMPQ), short-form 36 (SF-36), Pittsburgh sleep quality index (PSQI) before and after the study.
Read the detailed description
After COVID-19, musculoskeletal pain, anxiety, and sleep problems can continue. The study aimed to investigate the effects of strengthening and relaxation exercises on pain, anxiety, and sleep quality. The study was performed at Gaziosmanpaşa Education and Research Hospital with 76 post-covid patients that were randomized into experimental and control groups. Experimental group patients performed strengthening and relaxation exercises 3 times a week for 8 weeks. Control group patients did not perform any program. All participants were assessed with McGill Pain Scale short form (SFMPQ), short-form 36 (SF-36), and Pittsburgh sleep quality index (PSQI) before and after the study.
- Conditions
- COVID-19
- Being tested
- Exercise
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Strengthening and Relaxation Exercises
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Performed strengthening and relaxation exercises 3 times a week for 8 weeks. Receives: Other: Exercise |
| Control Group | No intervention | There is no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
McGill Pain Scale short form (SFMPQ)
It gives an information about the sensation, severity and effect of pain
Measured: at the enrollment and after the study
Short-Form 36 (SF-36)
It asses general quality of life with 8 parameters
Measured: at the enrollment and after the study
Pittsburg Sleep Quality Index
It asses sleep quality with 19 questions that each question scored between 0-3.
Measured: at the enrollment and after the study
Beck Anxiety Scale
It asses anxiety levels with subjective and somatic factors
Measured: at the enrollment and after the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start18 Jan 2021
- Primary completion31 Mar 2021
- Study completion8 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Saka, Halic University
- Investigators
- Seda Saka, PhD, Study director, Haliç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05435456
- Sponsor's protocol ID
- ssaka7
- Status last verified
- Jun 2022
- First submitted
- 26 Jun 2022
- Last updated
- 28 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carfi A, Bernabei R, Landi F; Gemelli Against COVID-19 Post-Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19. JAMA. 2020 Aug 11;324(6):603-605. doi: 10.1001/jama.2020.12603.
PubMed 32644129Liu K, Chen Y, Wu D, Lin R, Wang Z, Pan L. Effects of progressive muscle relaxation on anxiety and sleep quality in patients with COVID-19. Complement Ther Clin Pract. 2020 May;39:101132. doi: 10.1016/j.ctcp.2020.101132. Epub 2020 Mar 6.
PubMed 32379667
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Strengthening and Relaxation Exercises on Musculoskeletal Pain, Anxiety, and Sleep Quality on Post-covid Symptoms
- ClinicalTrials.gov ID
- NCT05435456
- Acronym / sponsor ID
- ssaka7
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 8 Jul 2021 (actual)
- First posted
- 28 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aimed to investigate the effects of strengthening and relaxation exercises on pain, anxiety, and sleep quality. 76 post-covid patients were randomized into experimental and control groups. Experimental group patients performed strengthening and relaxation exercises 3 times a week for 8 weeks. Control group patients did not perform any program. All participants were assessed with McGill Pain Scale short form (SFMPQ), short-form 36 (SF-36), Pittsburgh sleep quality index (PSQI) before and after the study.
Detailed description
After COVID-19, musculoskeletal pain, anxiety, and sleep problems can continue. The study aimed to investigate the effects of strengthening and relaxation exercises on pain, anxiety, and sleep quality. The study was performed at Gaziosmanpaşa Education and Research Hospital with 76 post-covid patients that were randomized into experimental and control groups. Experimental group patients performed strengthening and relaxation exercises 3 times a week for 8 weeks. Control group patients did not perform any program. All participants were assessed with McGill Pain Scale short form (SFMPQ), short-form 36 (SF-36), and Pittsburgh sleep quality index (PSQI) before and after the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: ExercisePerformed strengthening and relaxation exercises 3 times a week for 8 weeks. |
| Control Group | No intervention | –There is no intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- to be between the ages of 18-65
- to be diagnosed with Covid-19 in the last 3 months
- to have a negative PCR test, or to have completed the 14-day isolation period
Key exclusion criteria (2 listed)
- have undergone surgery in the last 6 months
- have severe mental retardation that would prevent communication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseStrengthening and Relaxation Exercises | Other | Experimental Group |
Primary outcome
McGill Pain Scale short form (SFMPQ)
Time frame: at the enrollment and after the study
It gives an information about the sensation, severity and effect of pain
Short-Form 36 (SF-36)
Time frame: at the enrollment and after the study
It asses general quality of life with 8 parameters
Pittsburg Sleep Quality Index
Time frame: at the enrollment and after the study
It asses sleep quality with 19 questions that each question scored between 0-3.
Beck Anxiety Scale
Time frame: at the enrollment and after the study
It asses anxiety levels with subjective and somatic factors
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- Background: PubMed 32644129Carfi A, Bernabei R, Landi F; Gemelli Against COVID-19 Post-Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19. JAMA. 2020 Aug 11;324(6):603-605. doi: 10.1001/jama.2020.12603.
- Results publication: PubMed 32379667Liu K, Chen Y, Wu D, Lin R, Wang Z, Pan L. Effects of progressive muscle relaxation on anxiety and sleep quality in patients with COVID-19. Complement Ther Clin Pract. 2020 May;39:101132. doi: 10.1016/j.ctcp.2020.101132. Epub 2020 Mar 6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seda Saka, PhD study director
Haliç University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with COVID-19, run by Halic University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
McGill Pain Scale short form (SFMPQ) (time frame: at the enrollment and after the study). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05435456, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2022.